510(k) K212382 · FDS Gastroscope And Accessories, Flexible/Rigid
Ambu® aScope Gastro, Ambu® aBox2
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Feb 3, 2022 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212382
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.